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Certivo

Certivo

Certivo 是為臨床試驗、製藥、醫療器材與生命科學等受規範產業設計的電子簽章平台,從基礎支援符合 FDA 21 CFR Part 11 的稽核記錄、角色存取、長期保存與多因素驗證。

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Certivo is an electronic signature platform purpose-built for regulated industries — clinical trials, pharma, medical devices, and life sciences. Unlike general-purpose e-signature tools, every feature is designed around FDA 21 CFR Part 11 compliance from the ground up. Features include ALCOA+ compliant audit trails with hash-chain verification, 25-year document retention, workflow automation, role-based access control, and built-in MFA. Compliant with FDA, EU CTR 536/2014, MHRA 2026, and GDPR.

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